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FDA 510(k) Application Details - K014181
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K014181
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD. MS 0491
ANDOVER, MA 01810-1099 US
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Contact
MIKE HUDON
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
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More FDA Info for this Product Code
Date Received
12/20/2001
Decision Date
01/15/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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